AssesSment of Early-deteCtion basEd oN liquiD Biopsy in PANCEATIC Cancer (ASCEND-PANCREATIC)

NCT ID: NCT05556603

Last Updated: 2023-05-06

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 7062 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-12-28
• Study Completion Date: 2029-12-31

Brief Summary

ASCEND-PANCREATIC is a prospective, multi-omics, observational study aimed at early detecting pancreatic cancer by combined assays for biomarkers of cfDNA methylation, circulating tumor DNA (ctDNA) mutation, serum protein markers and blood miRNA markers, in which of 7,062 participants will be enrolled. The development and validation of the model will be conducted in participants with early stage cancers or benign diseases, along with healthy individuals. The performance of the pancreatic cancer detection test will be evaluated in participants with high risk of pancreatic cancer.

Conditions

Cancer

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Cancer arm

Participants with new diagnosis of pancreatic cancer, from whom a blood sample will be collected.

No interventions assigned to this group

Benign disease arm

Participants with benign pancreatic diseases, from whom a blood sample will be collected.

No interventions assigned to this group

Healthy arm

Participants with no known presence of malignancies or benign diseases, from whom a blood sample will be collected.

No interventions assigned to this group

High risk for pancreatic cancer arm

Participants with high risk for pancreatic cancer, from whom a blood sample will be collected.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Age 40-75 years old.
• Able to provide a written informed consent.
• No prior cancer treatment (local or systematic) with either of the following:

A. Pathologically confirmed cancer diagnosis within 42 days prior to blood draw.

B. High suspicious for cancer diagnosis by imaging tests or other routine clinical examinations, with confirmed pathological cancer diagnosis within 42 days after the blood draw.

• Age 40-75 years old.
• Able to provide a written informed consent.
• Able to provide sufficient and qualified blood samples for study tests.
• Have either of the following:

A. Pathological confirmed diagnosis of benign diseases within 90 days prior to the study blood draw, with no prior treatment such as surgical resection.

B. High suspicious for benign diseases diagnosis by radiological or other routine clinical assessments, with confirmed benign diseases diagnosis within 42 days after study blood draw.

• Age 40-75 years at the day of consenting to the study.
• Able to provide a written informed consent.
• Able to provide sufficient and qualified blood samples for study tests.
• No cancer related symptoms within 30 days prior to study screening.
• No abnormal medical examination within 30 days prior to screening.
• Cancer history with curative treatment completed over 3 years without recurrence prior to study enrollment.

• Age 40-75 years old.
• Able to provide a written informed consent.
• Able to provide sufficient and qualified blood samples for study tests.
• Accompanied by known risk factors of pancreatic cancer, including carrier of any pathogenic variant, chronic pancreatitis and other risk factors.

Exclusion Criteria

• Insufficient qualified blood samples.
• During pregnancy or lactation.
• Recipient of organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant.
• Recipient of blood transfusion within 7 days prior to blood draw.
• Recipient of anti-tumor drugs to treat non-cancer diseases within 30 days prior to blood draw.
• With other known malignant tumors or multiple primary tumors.

• Insufficient qualified blood sample for study test.
• During pregnancy or lactation.
• Recipient of organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant.
• Recipient of blood transfusion within 7 days prior to study blood draw.
• Recipient of anti-tumor drugs to treat non-cancer diseases within 30 days prior to blood draw.

• Insufficient qualified blood sample for study test.
• During pregnancy or lactation.
• Recipient of organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant.
• Recipient of blood transfusion within 7 days prior to study blood draw.
• Recipient of anti-tumor drugs to treat non-cancer diseases within 30 days prior to blood draw.
• Have received or are undergoing curative cancer treatment within three years prior to study screening.
• With autoimmune or other diseases with severe comorbidities.

• Insufficient qualified blood sample for study test.
• During pregnancy or lactation.
• Recipient of organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant.
• Recipient of blood transfusion within 7 days prior to study blood draw.
• Recipient of anti-tumor drugs to treat non-cancer diseases within 30 days prior to blood draw.
• Received radical therapy within 3 years and without recurrence, with malignant tumors with pathogenic or suspected pathogenic variants of germ-line genetic susceptibility genes.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Guangzhou Burning Rock Dx Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Ruijin Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Baiyong Shen, M.D.&Ph.D

Role: STUDY_DIRECTOR

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Locations

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Site Status: ACTIVE_NOT_RECRUITING

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Site Status: ACTIVE_NOT_RECRUITING

Countries

China

Central Contacts

Qian Zhan, M.D.

Role: CONTACT

zhanxi80@126.com

+86-021-64370045 ext. 670903

Yuzi Zhang, M.D.

Role: CONTACT

Z_Zhangyuzi@163.com

+86-021-60293798

Facility Contacts

Qian Zhan, MD

Role: primary

zhanxi80@126.com

+86-021-64370045 ext. 670903

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Other Identifiers

RSCD2022003

Identifier Type: -

Identifier Source: org_study_id